ORALLINE KIDS- sodium fluoride gel, dentifrice

OralLine Kids by

Drug Labeling and Warnings

OralLine Kids by is a Otc medication manufactured, distributed, or labeled by J.M. Murray Center Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1

Purpose

Anticavity Toothpaste

Use

Use - Helps protect against cavities

Directions

Adults and children 2 years of age and older.  Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor. 

Children under 6 years of age.  Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing.  Supervise children as necessary until capable of using without supervision.

Warnings

If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately.

Keep Out of Reach of Children

Children under 2 years of age consult a doctor or a dentist

Keep out of the reach of children under 6 years of age.

Product Labels

OraLine Kids Fluoride Toothpaste ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed

No animal based ingredients. Mint Flavor Net Wt

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INGREDIENTS AND APPEARANCE

ORALLINE KIDS 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55873-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55873-003-01	113.4 g in 1 TUBE; Type 0: Not a Combination Product	01/01/1966

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1966

ORALLINE KIDS 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55873-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Mint Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55873-004-01	113.4 g in 1 TUBE; Type 0: Not a Combination Product	01/01/1966
2	NDC: 55873-004-02	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/1966

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1966

Labeler - J.M. Murray Center Inc. (071601108)

Registrant - J.M. Murray Center Inc. (071601108)

Establishment
Name	Address	ID/FEI	Business Operations
J.M. Murray Center Inc.		071601108	repack(55873-003, 55873-004) , relabel(55873-003, 55873-004)